PHARMACY

Pipex files NDA with FDA for copper regulating drug

BY Drew Buono

ANN ARBOR, Mich. Pipex Pharmaceuticals has filed a new drug application with the Food and Drug Administration for Coprexa, a treatment for Wilson’s disease, a genetic disorder in which the body is unable to clear excess free copper.

The company has just completed a 20 patient, one-year, open-label Phase I/II trial in refractory idiopathic pulmonary fibrosis patients and is planning a Phase III trial for Wilson disease patients.

The drug is used to reduce toxic free copper in serum. At the beginning of the week, Pipex had entered into a cooperative research and development agreement with the Veterans Affairs Medical Center to evaluate Coprexa.

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IMPAX announces limited resumption of sales of oxycodone

BY Drew Buono

STAMFORD, Conn. IMPAX Laboratories and its distributor DAVA Pharmaceuticals will resume sales of its oxycodone hydrochloride extended-release tablets in a limited capacity starting today.

This is in response to an agreement the companies signed with Purdue Pharma, who manufactures the brand version, Oxycontin, which is used for the management of moderate to severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The agreement said that IMPAX acknowledged that Purdue’s patents for Oxycontin were valid, enforceable and infringed on by their generic version. Purdue in return, allowed the companies to continue selling the product on the market until June 14, and to resume the distribution at a future date for a limited period of time.

The sales of the generic are expected to continue until around Jan. 28, 2008, or until the company’s sales quota under the license agreement with Purdue has been reached.

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Isis grants Excaliard license for development of antisense drugs

BY Drew Buono

CARLSBAD and ENCINITAS, Calif. Isis and Excaliard Pharmaceuticals have entered into an agreement to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring. Isis has granted Excaliard an exclusive worldwide license for the development and commercialization of certain antisense drugs.

Under the agreement, Excaliard made an upfront payment in the form of equity and paid $1 million cash to Isis for the licensing of a particular gene target. Isis will also be eligible to receive development milestones and royalties on antisense drugs developed by Excaliard.

“Isis has made superb progress in the development of second-generation antisense drugs over the last few years, as evidenced by its clinical pipeline and current collaborations with companies such as Bristol-Myers Squibb, Eli Lilly and Ortho-McNeil, among others,” said Excaliard co-founder J. Gordon Foulkes, acting chief executive officer for Excaliard and managing director of RiverVest Venture Partners. “Having access to Isis’ antisense technology and expertise provides a great opportunity for Excaliard.”

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